EMEA-002470-PIP01-18 - paediatric investigation plan

N-benzyl-2-(5-(4-(2-morpholinoethoxy)phenyl) pyridin-2-yl) acetamide (KX2-391)

Key facts

• Active substance:
  N-benzyl-2-(5-(4-(2-morpholinoethoxy)phenyl) pyridin-2-yl) acetamide (KX2-391)
• Therapeutic area:
  Dermatology
• Decision number:
  P/0075/2019
• PIP number:
  EMEA-002470-PIP01-18
• Pharmaceutical form(s):
  Ointment
• Condition(s) / indication(s):
  Treatment of actinic keratosis
• Route(s) of administration:
  Cutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  22/03/2019
• Compliance check done:
  No

Decision

P/0075/2019: EMA decision of 22 March 2019 on the granting of a product specific waiver for n-benzyl-2-(5-(4-(2-morpholinoethoxy)phenyl) pyridin-2-yl) acetamide (KX2-391) (EMEA-002470-PIP01-18)

Adopted Reference Number: EMA/145319/2019